Validation Engineer
Pfizer Inc - Middleton, WI

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Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
Responsible for oversight and performance of validation on processes, computerized systems, cleaning methods, equipment, facilities, systems and utilities. Develops cycles for new processes; helps troubleshoot product problems related to validation and scale-up. Performs testing and documents results for review by site, corporate and government review. Responsible for extensive knowledge of all process equipment in order to comprehensively explain their function and design. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach.

Responsibilities
  • Designs, executes validation protocols; and summarizes studies to ensure consistency of data production and compliance with Pfizer’s quality standards, with current Good Manufacturing Practices and national/international standards.
  • Responsible for developing/executing matrix validations (where applicable) for processes and equipment with adequate supporting rationales.
  • Responsible for oversight and performance of validation for production processes, and writes process validation protocols and final report packages. Generates, executes and summaries Product Process Qualifications for the entire scope of the production processes. Extensive understanding of all production processing steps and thorough knowledge of required validations for compliance with Pfizer’s quality specifications.
  • Evaluates equipment or process problems and designs testing to determine possible causes or solutions; determines process capability of new equipment and assures defined parameters are incorporated into respective operating procedures and batch records.
  • Provides validation input at new product/process team meetings. Responsible for ensuring product development activities have all necessary validations and supporting justifications.
  • Responsible for ensuring all applicable process documentation is created, revised, and in-place to guarantee production processing consistent within validated parameters.
  • Responsible for providing direction to colleagues concerning protocol execution for protocols under their management.
  • Capable of managing multiple projects
  • Responsible for generating Validation Plans, Functional Specifications and Critical Step Analyses.
  • Issues data, memos and reports concerning validation projects.
ORGANIZATIONAL RELATIONSHIPS

Interfaces with management and non-management personnel, third party representatives, and external validation personnel.

Qualifications
BS in a Science or Engineering related field.

Grade 004 - Two to six years relevant experience
Grade 007 - Six to ten years relevant experience

TECHNICAL SKILLS REQUIREMENTS

  • Comprehensive working knowledge of the theory, function and operation of production equipment, for example (but not limited to) the following: Automated Process equipment, SCADA systems, LPLC columns, CIP & COP equipment, WFI/Purified Water generation and distribution systems, Building Management and HVAC systems, Freezers, Refrigerators, etc.
  • A strong working knowledge of specific laboratory equipment, for example Organism ID Systems, HPLCs & GCs, TOC analyzers, etc.
  • Ability to interact with Industrial Computers such as Allen Bradley PLCs using ladder logic programming and SCADA systems such as GE Fanuc iFix.
  • Advanced knowledge of Microsoft Office (Word, Excel, Access)
  • A strong working knowledge of Lean and Six Sigma tools and techniques, such as Pareto charts, cause and effect diagrams, control charts, regression, designed experiments, etc.
  • Strong technical writing ability. Writes clearly and informatively, able to express complex ideas in a clear, concise manner; capable of explaining technical issues to non-technical personnel.
  • Able to effectively function and/or lead in a cross-functional team environment to ensure validation requirements and testing are realized. Contributes to building a positive team spirit. Treats others with respect and consideration regardless of their status or position.
  • Able to deal with frequent change, delays, or unexpected events.Displays original thinking and creativity; meets challenges with resourcefulness.
  • Exhibits sound and accurate judgment. Exercises good judgment and recognition with process and/or validation deviations (excursions) for appropriate resolution.
PHYSICAL POSITION REQUIREMENTS

The work environment characteristics and physical described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to wet or humid conditions (non-weather); work near moving mechanical parts; work in high, precarious places; fumes or airborne particles; toxic or caustic chemicals; extreme cold (non-weather); extreme heat (non-weather) and risk of electrical shock; the noise level in the work environment is usually moderate; required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear and taste or smell; must occasionally lift and/or move up to 25 pounds; specific vision abilities required by this job include ability to adjust focus.

Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

Pfizer Inc - 19 months ago - save job - block
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Pfizer pfabricates pfarmaceuticals pfor quite a pfew inpfirmities. The company is the world's largest research-based pharmaceuticals...